Investor Meeting on Q1 FY2017 Results · Q1 FY2017 Financial Highlights Double-digit growth in...
Transcript of Investor Meeting on Q1 FY2017 Results · Q1 FY2017 Financial Highlights Double-digit growth in...
Copyright© 2017 Santen Pharmaceutical Co., Ltd. All rights reserved.
Investor Meeting on
Q1 FY2017 Results
August 1, 2017
Kazuo Koshiji
Senior Corporate Officer
Chief Financial Officer (CFO)
Head of Finance Division
Santen’s Values
By focusing on ophthalmology, Santen develops unique
scientific knowledge and organizational capabilities that
contribute to the well-being of patients, their loved ones
and consequently to society.
1
2
To Become a Specialized Pharmaceutical Company
with a Global Presence
Rank #5 globally
Overseas sales:
16% of total sales
Overseas sales:
30% of total sales
-Strengthen Japan business
-Completed preparation for business expansion in Asia/EMEA
Plan Results
Product
Development
-Transform product development to realize enhanced productivity and achieve sustained growth
-Active investment in sustainable growth
-Approval, Launch: Tapcom, Ikervis -Development: progress of DE-109, 117, 122 -Licensing, Acquisition: DE-126, 128
Business
Expansion
-Grow business in Asia/EMEA and strengthen market presence by entering into new markets
-Raised new products sales ratio in Japan: from 44% (FY13) to 71% (FY16) -Growth in market share of OTC products in Japan -Strengthened internal sales platform in Asian countries -Grew the number EMEA countries with sales
Organization
and Talent
-Develop talent and organization to realize sustained growth and strengthen the global management system
-Introduced new HR appraisal system -Held training aimed at nurturing the next generation of
employees / managers
2014~2017 2020 ~2013
Current Mid-Term Plan (MTP)
-Grow business in Asia/EMEA and improve profitability
-Prepare for business expansion to the U.S. and other regions
“To Become a Specialized Pharmaceutical Company with a Global Presence”
Become Global Top 3
Overseas sales:
40~50% of total sales
3 3
Q1 FY2017 Financial Results
ended June 30, 2017
4
Q1 FY2017 Financial Highlights Double-digit growth in revenue and profit
Higher revenue and profit as revenue growth both in Japan and overseas more than offset higher SG&A and R&D expenses
◆Revenue: 55.9 bil yen, up 11.9% (YoY)
・Japan pharma 34.8 bil yen (+5.4%), OTC 4.0 bil yen (+35.3%)
・Asia 7.3 bil yen (+21.4%), EMEA 8.7 bil yen (+29.1%)
◆Operating profit: Core basis 13.7 bil yen, up 10.9% (YoY); IFRS 12.1 bil yen, up 11.5% (YoY)
(JPY billions) FY2016
Q1 Q1 Full year
Core basis actual actual forecast
Revenue 50.0 55.9 11.9% 218.0 25.7%
COGS -18.4 -21.6 17.3% -81.0 26.6%
Gross margin 31.6 34.4 8.7% 137.0 25.1%
SGA -14.1 -15.1 6.8% -68.0 22.1%
R&D expenses -5.2 -5.6 8.8% -25.0 22.5%
OP 12.4 13.7 10.9% 44.0 31.1%
Net profit 8.8 10.0 14.0% 31.2 32.0%
IFRS
OP 10.8 12.1 11.5% 37.4 32.2%
Net profit 7.3 8.9 21.7% 26.8 33.3%
USD 108.83 111.33 -2.3% 110.00 -1.2%
EUR 122.53 122.95 -0.3% 120.00 -2.5%
CNY 16.63 16.22 2.5% 16.50 1.7%
+: JPY appreciation, -: JPY depreciation
FY2017
YoY
vs FY
forecast
5
Q1
FY2017
55.9
Other
0.0
NPM*
0.2
(EMEA
currency impact)
0.0
EMEA
1.9
(Asia
currency
impact)
0.0
Asia
1.3
Surgical
0.0
OTC
1.0
Japan
Pharma
1.8
Q1
FY2016
50.0
Japan Overseas
Japan business Overseas business
Japan pharma
Revenue growth of new products,
mainly Eylea, Alesion, Diquas, helped
boost overall revenue +5.4%
Asia
Overall growth of 21.4% (JPY base) due to continuous
growth in China and S. Korea, and significant progress
in ASEAN market (+75.9%, JPY base)
OTC
In addition to inbound sales, good
progress in new products and sales
promotion for Japanese consumers
added to +35.3% revenue growth
EMEA Growth of acquired MSD products and Ikervis helped
boost revenue +29.1% (JPY base)
Surgical +4.7% growth supported by sales
collaborations with pharma business NPM No NPM from MSD with completion of MA transfers
33.0 2.9 0.7
↓ ↓ ↓
34.8 4.0 0.8
6.0
↓
7.3
6.7
↓
8.7
0.2 0.4
↓ ↓
0.0 0.4
* Net profit margin (NPM) relating to the US-based MSD product acquisition.
(JPY billions)
Q1 FY16 Q1 FY17
USD JPY 108.83 JPY 111.33
EUR JPY 122.53 JPY 122.95
CNY JPY 16.63 JPY 16.22
Q1 FY2017 Revenue All businesses contributing to higher growth
6
Q1
FY2017
13.7
Other
0.5
R&D
0.5
HQ
SGA
0.1
NPM
0.2
(US
currency
impact)
0.0
US
0.6
(EMEA
currency
impact)
0.0
EMEA
1.6
(Asia
currency
impact)
0.0
Asia
1.0
Surgical
0.1
OTC
0.4
Japan
Pharma
0.6
Q1
FY2016
12.4
Japan Overseas HQ
Japan business Overseas business
Japan pharma Decline reflects transitory factor that lowered COGS in same period of prior year
Asia Overall higher with revenue growth and expense management
OTC Overall higher with revenue growth EMEA
R&D expenses
Higher expenses due to pipeline progress (DE-117, 122, 126, 128)
US Preparation expenses for US entry increased
16.6 1.4 0.2
↓ ↓ ↓
16.0 1.8 0.1
1.3
↓
2.3
0.5
↓
2.0
-0.6
↓
-1.2
0.2 -2.4 -5.2 0.3
↓ ↓ ↓ ↓
0.0 -2.5 -5.6 0.8
(JPY billions)
Q1 FY16 Q1 FY17
USD JPY 108.83 JPY 111.33
EUR JPY 122.53 JPY 122.95
CNY JPY 16.63 JPY 16.22
Q1 FY2017 Core Operating Profit High contributions from overseas operations
7
Performance by Business (Japan)
Q1
FY14
31.7
24.3
Q1
FY15
+7%
33.0
Q1
FY16
34.8
Q1
FY17
Q1
FY13
26.3
15.9
12.5
10.6
16.0
+6%
16.6
2.4 2.9
Q1
FY14
Q1
FY13
Q1
FY15
1.4
4.0 +26%
Q1
FY16
Q1
FY17
1.6
1.8 1.4
+54%
0.3 0.4
1.1
Q1
FY16
0.7
+5%
Q1
FY17
0.8
Q1
FY14
0.7
Q1
FY15
0.7
Q1
FY13
0.6
0.1 0.2
-0.2
0.3
+1%
0.1
(JPY billions, CAGR%) 【Japan pharma】 【OTC】 【Surgical】
Increase in revenue on sales of new products, such as Eylea; Removing transitory factor in Q1 FY16, Q1 FY17 OP increased YoY; Going forward in FY17 efforts being made to increase profit through sales from higher margin products like Alesion
In addition to FX (inbound sales
and domestic promotion),
Beauteye (inbound sales), good
progress in new products
launched in prior autumn
Sales
OP
before R&D
8
+25%
Q1
FY17
7.3
Q1
FY16
6.0
Q1
FY13
3.0
Q1
FY15
6.3
Q1
FY14
3.8
2.3
1.3
2.2
1.0
0.5
+46%
6.0
Q1
FY15
5.4
Q1
FY14
3.7
Q1
FY13
3.3
+22%
Q1
FY17
7.3
Q1
FY16
1.3
2.3
1.9
1.0
0.6
+43%
Good market penetration of Santen products particularly in
China, S. Korea and Vietnam and other countries;
Business platform enhancements proceeding well – striving
for continuous growth with gross margin improvement
exceeding additional investments
Performance by Business (Asia)
Sales
OP
before R&D
Local currency base
(Conversion with FY2017 forecast rate for all FY)
(JPY billions, CAGR%)
9
Q1
FY2013
2.9
+31%
Q1
FY2017
8.7
Q1
FY2016
6.7
Q1
FY2015
5.4
Q1
FY2014
3.3
+67% 2.0
0.5
-0.4
0.0 0.3
70.6
54.9
40.1
23.222.8
+33%
Q1
FY2017
Q1
FY2016
Q1
FY2015
Q1
FY2014
Q1
FY2013
16.5
3.9
-3.0
0.32.0
+70%
Continuous good market penetration of both Santen and MSD
products in glaucoma area (YoY: Cosopt +7.7%, Tapros +20.6%,
Trusopt +12.4%);
Ikervis growth (YoY: +190.9%) above expectation at start of FY17
Performance by Business (EMEA)
Sales
OP
before R&D
Local currency (EUR millions) (JPY billions, CAGR%)
10
FY2017 P&L Forecast (No change from May 10)
Revenue: Growth forecast in all businesses, particularly overseas
Operating profit: Increased spending on future growth (listed below), while also strengthening cost control systems. OP is forecast to increase. ・ Investments in pipeline progress and the maximization of product value ・ Investments in US entry preparation
Core basis
IFRS Amortization on intangible assets associated with products will change substantially; non-recurring items; revenue and core operating profit to grow in proportion
(JPY billions) FY2016
Core basis
Revenue 199.1 218.0 9.5%
COGS -75.0 -81.0 8.1%
SGA -61.7 -68.0 10.3%
R&D expenses -22.8 -25.0 9.7%
Operating profit 39.7 44.0 10.9%
Net profit 28.7 31.2 8.8%
ROE 11.2% 12.3% 1.1pt
IFRS
Operating profit 32.5 37.4 15.2%
Net profit 23.1 26.8 16.2%
ROE 9.0% 10.6% 1.6pt
USD 108.64 110.00
EUR 118.96 120.00
CNY 16.14 16.50
FY2017
Actual Forecast YoY
Payout-ratio (%)
39.3% 46.3%
19.4%
37.8%
41.9%
51.1%
50.8%
36.0%
36.3%
67.2% 54.7%
42.9%
39.9%
39.7%
55.8%
21.4%
810
12 13
16 16 1618
20 20 2022
25 26 26
4
FY17Fct
-
39.3%
FY16
12.3
100.2%
FY15
-
19.4%
FY14
-
37.8%
FY13
-
41.9%
FY12
13.7
134.4%
FY11
-
50.8%
FY10
-
36.0%
FY09
-
36.3%
FY08
-
67.2%
FY07
4.8
92.3%
FY06
-
42.9%
FY05
-
39.9%
FY04
2.6
62.8%
FY03
-
55.8%
FY02
3.2
59.1%
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FY2017 Dividends Forecast (No change from May 10)
* The company implemented a 5-for-1 stock split on April 1, 2015. Accordingly, the calculations of annual dividend per share have been adjusted in all periods
for comparison purposes.
** J-GAAP standards used until FY13, IFRS applied from FY14.
Share buyback (b yen) Total return
FY2014-FY2017 Shareholder Return Policy • Stable and sustained return to shareholders
• Maintain a sound and flexible financial position to enable product acquisitions and M&A for future growth
• Consider share buybacks in a flexible manner
• Aim to maintain a dividend payout ratio of about 40%
Removing anti-RA transfer impact, FY15 payout ratio estimated at 35%
Annual dividend per share (JPY)
Annual Dividends
FY2016:
JPY26 / share
FY2017 (forecast):
JPY26 / share
12 12
Reference
13
Q1 FY2017 Profit / Loss
・OTC +0.3 bil yen,
・Asia +0.3 bil yen, EMEA -0.1 bil yen, US +0.6 bil yen
・HQ admin +0.1 bil yen
・Decreased actual tax ratio due to increase of profit before tax and tax incentive on R&D expenses at HQ
Q1 FY16 Q1 FY17
USD JPY 108.83 JPY 111.33
EUR JPY 122.53 JPY 122.95
CNY JPY 16.63 JPY 16.22
Q1 FY16 Q1 FY17
(JPY billions)
Revenue 50.0 55.9 11.9%
COGS -18.4 -36.8% -21.6 -38.6% 17.3%
SGA expenses -14.1 -28.2% -15.1 -26.9% 6.8%
R&D expenses -5.2 -10.3% -5.6 -10.0% 8.8%
Amortization on intangible
assets assosiated with
products
-1.6 -3.2% -1.7 -3.0% 4.4%
Other income 0.1 0.2% 0.1 0.1% -24.8%
Other expenses -0.1 -0.1% -0.1 -0.1% 4.3%
Operating profit (IFRS) 10.8 21.6% 12.1 21.5% 11.5%
Finance income 0.4 0.9% 0.5 0.8% 5.6%
Finance expenses -1.0 -2.0% -0.3 -0.5% -69.8%
Profit before tax 10.3 20.5% 12.2 21.8% 19.1%
Income tax expenses -2.9 -5.9% -3.3 -5.9% 12.4%
Actual tax ratio 28.6% 27.0% -1.6pt
Net profit (IFRS) 7.3 14.6% 8.9 15.9% 21.7%
Core operating profit 12.4 24.7% 13.7 24.5% 10.9%
Core net profit 8.8 17.5% 10.0 17.9% 14.0%
YoYActualvs
RevenueActual
vs
Revenue
14
Q1 FY2017 Financial Position
109.8
64.9
102.0
325.6
50.3
14.7
260.6 (80%)
325.6
49.0
322.8
53.4
15.5
253.9 (79%)
322.8
53.3
103.7
63.0
102.8
※
March 31, 2017
Intangible assets
Other non-
current assets
Current assets
Cash and cash
equivalents
Equity
Non-current
liabilities
※ Current liability
June 30, 2017
Increase of trade receivables due to cash receipt timing, and decrease of cash due to tax and dividend payments
63.0
53.3 53.4
Non-current assets
165.8
Current assets
157.0
Non-current assets
166.8
Current assets
158.7
(JPY billions)
March 31,
2017
June 30,
2017Change
Non-current assets 165.8 166.8 1.1
Property, plant and equipment 28.6 28.6 0.1
Intangible assets 102.8 102.0 -0.8
Financial assets 29.9 31.8 1.9
Other 4.5 4.5 -0.1
Current assets 157.0 158.8 1.7
Inventories 28.5 27.0 -1.5
Trade and other receivables 71.0 77.1 6.1
Cash and cash equivalents 53.3 49.0 -4.3
Other 4.2 5.7 -1.4
Non-current liabilities 15.5 14.7 -0.8
Financial liabilities 7.6 6.1 -1.5
Deferred tax liabilities 2.6 3.6 1.0
Other 5.3 4.9 -0.3
Current liabilities 53.4 50.3 -3.1
Trade and other liabilities 23.9 23.7 -0.2
Other financial liabilities 17.6 14.7 -2.9
Income tax payable 3.3 3.2 0.0
Other 8.6 8.6 0.0
Equity 253.9 260.6 6.8
15
Q1 FY2017 Segment Revenue
Q1 FY17 Segment Revenue
(JPY billions) YoY YoY YoY
Pharamaceuticals 39.0 7.8% 16.3 24.0% 55.2 12.1%
Prescription 35.0 5.5% 16.2 23.8% 51.2 10.7%
Ophthalmic 34.9 5.5% 16.1 26.8% 50.9 11.4%
Others 0.2 16.2% 0.1 -64.9% 0.3 -44.2%
OTC 3.9 33.1% 0.1 154.1% 4.0 34.1%
Others 0.7 1.5% 0.0 -76.3% 0.7 -2.7%
Medical devices 0.6 -1.7% 0.0 -13.4% 0.6 -1.8%
Others 0.1 22.1% 0.0 -86.8% 0.1 -6.8%
Total 39.7 7.7% 16.3 23.7% 55.9 11.9%
Sales ratio 70.9% 29.1%
Revenue Revenue Revenue
TotalJapan Overseas
16
Capital Expenditures/Depreciation & Amortization
* Excludes amortization on intangible assets associated with products and long-term prepaid expenses
Q1 Full year Full year
Actual Actual Actual YoY Forecast
1.6 5.2 1.0 -37.6% 7.7
0.8 3.5 1.0 24.8% 3.8
1.6 6.4 1.7 4.4% 6.6
Intangible assets
-Merck products1.3 5.4 1.4 4.7% 5.6
Intangible assets
-Ikervis0.2 0.7 0.2 0.0% 0.7
Amortization on intangible assets
associated with products
FY2017FY2016
Q1(JPY billions)
Capital expenditures
Depreciation and amortization*
Market Overview of Prescription Ophthalmic
in Japan
Source: Copyright © 2017 QuintilesIMS. IMS-JPM 2016-17 Santen analysis based on IMS data. Reprinted with permission
JPY billions ValueChange
(YoY)Value
Change
(YoY)Value
Change
(YoY)Value
Change
(YoY)
Total 38.9 6.7% 86.6 1.2% 44.9% #1 41.4 6.5% 90.4 4.3% 45.8% #1
Anti-glaucoma 9.4 2.6% 29.2 4.0% 32.3% #1 9.2 -2.2% 29.3 0.5% 31.4% #1
Anti-VEGF 13.2 22.4% 18.5 -1.3% 71.2% #1 15.1 14.6% 21.1 14.1% 71.5% #1
Corneal/dry eye 7.1 -2.6% 11.4 -0.8% 62.8% #1 7.3 3.0% 11.8 3.5% 62.5% #1
Anti-allergy 3.4 26.6% 8.2 14.5% 41.8% #1 4.1 20.9% 8.9 8.8% 46.4% #1
Anti-infection 1.8 -19.4% 3.9 -9.6% 45.5% #1 1.5 -13.0% 3.7 -4.2% 41.3% #1
ValueChange
(YoY)Value
Change
(YoY)
Total 159.8 3.0% 349.3 0.2% 45.8% #1
Anti-glaucoma 36.6 -1.1% 114.5 0.6% 31.9% #1
Anti-VEGF 55.9 8.8% 77.1 3.8% 72.5% #1
Corneal/dry eye 28.7 -1.6% 45.9 -0.8% 62.6% #1
Anti-allergy 16.9 23.5% 38.5 4.5% 44.0% #1
Anti-infection 6.2 -20.2% 14.4 -9.9% 43.0% #1
Jul 1, 2016 - Jun 30, 2017
Q1FY16 Q1FY17
Santen MarketSanten
share
Santen MarketSanten
share
Santen MarketSanten
share
17
Status of Research & Development Q1 FY2017
Senior Corporate Officer
Chief Scientific Officer (CSO)
Head of Global Research & Development
Naveed Shams, M.D., Ph.D.
19
Future Development and Regulatory Milestones
DE-117 P2b/3 Glaucoma/
ocular
hypertension Japan: Q2/Q3 FY17 filing
DE-126 P2b Glaucoma/
ocular
hypertension US/Japan: Jan~Jun 2018 P2b completion
DE-128 (MicroShunt)
P2/3 Glaucoma/
ocular
hypertension
US: calendar 2018~2019 P2/3 completion,
calendar 2020~2021 launch
DE-109 (IVT sirolimus)
Filing
Accepted Uveitis
US: Dec 24, 2017 PDUFA date;
Jan~Jun 2018 launch
P3 EU: 2nd half of FY17 re-filing
DE-122 P2a Wet AMD US: Jan~Jun 2019 P2a completion**,
FY17 P1/2 completion
Development region: milestone* Development
status*
As of August 1, 2017
*Updated information is underlined, **Conducting in the Philippines
Indication
Vekacia (Verkazia): In July 2017 EMA’s CHMP adopted positive opinion recommending
marketing authorization
20 20
Reference
DE-117 EP2 receptor agonist
US
JP P2b/3 on-going
Asia P3 on-going
DE-126 FP/EP3 dual receptor agonist
US Started P2b in Jul 2017
JP
DE-128 InnFocus MicroShunt
US P2/3 on-going
Europe CE mark granted
21
Pipeline / Product Development Status (1)
See Santen Consolidate Results for the 1st Quarter Fiscal 2017 for more details. “Asia” above excludes Japan and China.
Glaucoma/ ocular hypertension P1 P2 P3
Reg review
Launch Current status or updated information
P2b
P2b/3
P2/3
As of August 1, 2017
P2b
22
Pipeline / Product Development Status (2)
DE-109
IVT sirolimus
US Filed in Feb 2017
JP
Europe Preparing to re-file
Asia Filed in Apr 2015
DE-122 Anti-endoglin antibody
US Started P2a in Jul 2017
Retinal/ uveal disease
P2a
As of August 1, 2017
P1 P2 P3 Reg
review Launch Current status or updated information
See Santen Consolidate Results for the 1st Quarter Fiscal 2017 for more details. “Asia” above excludes Japan and China.
DE-089 Diquas
CN Filed in Jan 2012
DE-114A Epinastine HCl (high dose)
JP Started P3 in May 2017
Cyclokat Ikervis/ciclosporin
US
Asia Approved since Nov 2016
Others Filed in Canada in Apr 2016
Vekacia Verkazia/ciclosporin
Europe Filed and granted Priority Review status in
Dec 2016 and received positive CHMP
opinion in Jul 2017
Kerato- conjunctival disease P1 P2 P3
Reg review
Launch Current status or updated information
23
Forward-Looking Statements
Information given in this presentation contains certain forward-looking statements concerning forecasts, projections and plans whose realization is subject to risk and uncertainty from a variety of sources. Actual results may differ significantly from forecasts.
Business performance and financial condition are subject to the effects of medical regulatory changes made by the governments of Japan and other nations concerning medical insurance, drug pricing and other systems, and to fluctuations in market variables such as interest rates and foreign exchange rates.
The process of drug research and development from discovery to final approval and sales is long, complex and uncertain. Individual compounds are subject to a multitude of uncertainties, including the termination of clinical development at various stages and the non-approval of products after a regulatory filing has been submitted. Forecasts and projections concerning new products take into account assumptions concerning the development pipelines of other companies and any co-promotion agreements, existing or planned. The success or failure of such agreements could affect business performance and financial condition significantly.
Business performance and financial conditions could be affected significantly by a substantial drop in sales of a major drug, either currently marketed or expected to be launched, due to termination of sales as a result of factors such as patent expiry and complications, product defects or unforeseen side effects. Santen Pharmaceutical also sells numerous products under sales and/or manufacturing license from other companies. Business performance could be affected significantly by changes in the terms and conditions of agreements and/or the non-renewal of agreements.
Santen Pharmaceutical is reliant on specific companies for supplies of certain raw materials used in production. Business performance could be affected significantly by the suspension or termination of supplies of such raw materials if such and event were to adversely affect supply capabilities for related final products.